Mitral Valve Disease
The Mitral Valve is a complex structure positioned between the left atrium and the left ventricle.
Its function is to make unidirectional the blood flow from the left atrium to the left ventricle.
The Mitral Valve can be affected by two major dysfunctions:
Mitral Valve Stenosis (i.e. narrowing of the mitral valve orifice), and Mitral Valve Regurgitation (i.e. blood backflow into the left atrium).
Most Common Heart Valve Dysfunction
Mitral regurgitation (MR) is the most common heart valve dysfunction with an estimated 3.6M sufferers in the US and the EU alone. That number is projected to climb to 4.5M patients by 2025. Surgical repair is considered the “Gold Standard” in addressing MR, yet 98% of patients remain untreated due to the invasive nature of the surgery and prolonged recovery.
Current TMVR programs are falling short due to the complex and varied pathophysiology of the mitral valve. A trans-catheter solution specifically tailored to the complex pathophysiology of the mitral valve will revolutionize the treatment for millions of patients and represents a substantial market opportunity.
| 16M |
People with mitral valve disease in US & EU |
|---|---|
| ~1.7M requiring surgical intervention |
| 20% |
Expected growth by 2025 |
|---|---|
| to a total of 4.5M patients |
| $3.2B |
TMVR market opportunity by 2025 |
|---|---|
*Nkomo et al., “Burden of Valvular Heart Diseases”; S.J. Head, W. J., van Leeuwen, N.M., Van Mieghem, and A.P. Kappetein; September 2006
| 16M |
People with mitral valve disease in US & EU |
|---|---|
| ~1.7M requiring surgical intervention |
| 20% |
Expected growth by 2025 |
|---|---|
| to a total of 4.5M patients |
| $3.2B |
TMVR market opportunity by 2025 |
|---|---|
*Nkomo et al., “Burden of Valvular Heart Diseases”; S.J. Head, W. J., van Leeuwen, N.M., Van Mieghem, and A.P. Kappetein; September 2006
Most patients with MR untreated
Despite the long term clinical benefits mitral repair, most patients requiring surgery remain untreated due to:
• Invasiveness of the procedure
• Poor left ventricular function (low EF)
• Prolonged recovery
Head et al., “Surgical or transcatheter mitral valve intervention;” Back Bay Life Science Advisors, Strategic Market Analysis, Boston: 2018.
Mitral valve disease – most common
Percutaneous Aortic Valve Success
TAVR/TAVI global market valued at $6.3 Billion in 2023.
Projected to reach >$16B by 2030.
Burden of valvular heart diseases: a population-based study, Nkomo et al. – The Lancet vol.368 – 2006
Percutaneous Aortic Valve Success
TAVR/TAVI global market valued at $3.67 Billion in 2017.
Projected to reach $12.2B by 2025.
Burden of valvular heart diseases: a population-based study, Nkomo et al. – The Lancet vol.368 – 2006